DRAPES, DISPOSABLE SURGICAL— 510(k) K782051

Substantially Equivalent

Marco Mfg.

FDA 510(k) clearance K782051 for DRAPES, DISPOSABLE SURGICAL, Substantially Equivalent on 1979-03-21. Applicant: Marco Mfg.. Device class: 2.

Clearance details

Applicant: Marco Mfg.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1978-12-08
Decision date: 1979-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.